Earlier this year, the Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on donanemab, for the treatment of early symptomatic AD. In its decision, the CHMP cited an unfavourable benefit-risk balance: although donanemab slowed clinical decline over the 76-week study period, amyloid-related imaging abnormalities (ARIA) occurred in 36.8% of treated participants, compared to 14.9% of those receiving placebo. Consequently, the CHMP concluded that, even in a restricted population, the benefits did not outweigh the risks of serious adverse events.
Following the refusal, Eli Lilly requested a re-examination of the negative opinion for donanemab. Re-examination started on 2 June 2025 and the CHMP now has 60 days to re-examine its opinion, with a final outcome expected by the end of July. On 16 July 2025, Alzheimer Europe sent a statement, to the EMA. This statement, which emerges from a series of discussions with our members regarding anti-amyloid treatments at various meetings over the past year, supports a positive opinion on donanemab.
People living with Alzheimer’s disease and their families had welcomed the positive opinion on lecanemab in November 2024 and had similar hopes about the introduction of an additional treatment for patients in Europe. The CHMP recommendation means that Europeans with early Alzheimer’s disease may not have access to an additional anti-amyloid treatment which is available to patients in many other countries and regions.
Our position statement of 16 July identifies five key areas of concern for the European dementia community:
1. Refusal of donanemab risks creating disparities and worsening health inequalities
2. Approval of donanemab would support patient autonomy and provide choice for clinicians, patients and families
3. Targeted risk management strategies could enhance the benefit-risk profile of donanemab
4. Donanemab treatment can provide meaningful benefits to patients with early AD
5. Approval of donanemab could drive healthcare systems investment and maintain European competitiveness in R&D.
Alzheimer Europe recognises the importance of a thorough and independent assessment by the European Medicines Agency, and welcomes the attention it pays to patient safety in its evaluation of new medicines. However, the negative opinion on donanemab raises a number of concerns for patients, carers, clinicians, and health systems across Europe.
We urge the CHMP, in its re-examination, to carefully consider how a refusal of donanemab may affect equity, choice, and patient autonomy. Thirteen regulatory authorities around the world have approved donanemab based on the same scientific evidence currently being re-evaluated. The EMA’s negative opinion stands in contrast to these decisions and to its own approval of lecanemab, a medicine with a similar benefit-risk profile. A continued refusal would reduce access to an additional disease-modifying therapy that is already available to patients in many other countries.
Donanemab offers a further treatment option for people with early Alzheimer’s disease, with a different dosing regimen and stopping rules. Alongside lecanemab, it could support more personalised decision-making between patients, carers and clinicians, taking into account individual risk factors, preferences and treatment needs. Countries that have approved donanemab have implemented detailed safety protocols and targeted eligibility criteria. These measures help balance safety with access and could be adapted for use in the EU.
We encourage the EMA and the company to work together to define a clear patient population where the benefits of treatment outweigh the risks. The exclusion of patients with superficial siderosis, ApoE4 homozygotes and patients on anticoagulants could be part of such a strategy, as well as requirements for safety monitoring, eligibility restrictions, controlled access and the col-lection of real-world data through patient registries. Alzheimer Europe is encouraged by the availability of flexible dosing and titration strategies to reduce the risk of side effects without compromising clinical benefit.
Regulatory decisions also have broader consequences. Delays in access to new therapies risk slowing down investment in health systems and in research. The approval of additional treatments like donanemab could support reforms in diagnosis, care planning and service delivery, improving outcomes for people with dementia and their families.
Alzheimer Europe remains committed to a holistic approach to Alzheimer’s disease and dementia, where innovative new treatments are included alongside counselling, support and adequate care of people with dementia and their carers throughout the disease process. The organisation there-fore reiterates its call for continued research into other treatment options, including symptomatic therapies and treatments for people in more advanced stages of dementia.
Read our full statement, here: https://www.alzheimer-europe.org/sites/default/files/2025-07/2025-07-16_statement_on_re-examination_of_donanemab_0.pdf